Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K921432
Device Name SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact DE MINT
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/25/1992
Decision Date 05/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-